Department of Otorhinolaryngology, University of Lübeck, Campus Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.
Institute of Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany.
Sleep Breath. 2024 Dec;28(6):2501-2508. doi: 10.1007/s11325-024-03134-w. Epub 2024 Sep 6.
Mandibular advancement devices (MAD) are a well-established treatment option for obstructive sleep apnea (OSA). MAD are considered preferably for patients with mild to moderate OSA presenting with a elevated night-to-night variability (NNV). This study aimed to determine the treatment effect of MAD on NNV considering different protrusion distances and patient related outcome (PRO).
We conducted a prospective cohort analysis of patients before MAD with 60% and 80% of the maximum protrusion. OSA severity was assessed using a home-sleep test for two consecutive nights. PRO contained the Epworth Sleepiness Scale (ESS) and sleep related quality of life (FOSQ).
Twenty patients with a median overweight body-mass-index of 27.1 (interquartile range (IQR) 16.3 kg/m²), with a mainly mild to moderate OSA with an apnea -hypopnea index (AHI) of 18.3 / h (IQR 17.7) and elevated ESS of 12.5 (IQR 8.0) were included. As opposed to 80%, 60% protrusion significantly but not 80% relevantly reduced AHI (60%%: 11.2 (IQR 5.5)/h, p = 0.01; 80%: 12.9 (IQR18,0)/h, p = 0.32) and improved the ESS (60%: 8.0 (IQR 10,0); 80%: 10 (IQR 9.0)), with therapy settings. No correlation could be detected between NNV and ESS, and FOSQ changes. Higher baseline NNV was associated with severe OSA (p = 0.02) but not with gender, overweight, or status post-tonsillectomy.
OSA improvement is associated with lower NNV; both OSA and NNV are connected to the degree of protrusion. Therefore, higher NNV does not justify the exclusion of candidates for MAD treatment. PRO changes are not visibly affected by NNV but by general OSA changes. These findings may help to define and optimize future study designs for the primary outcome decision between objective OSA parameters and PRO.
下颌前伸装置(MAD)是治疗阻塞性睡眠呼吸暂停(OSA)的一种成熟的治疗方法。对于夜间变异性(NNV)升高的轻中度 OSA 患者,首选 MAD 治疗。本研究旨在探讨 MAD 治疗对 NNV 的影响,并考虑不同的前伸距离和患者相关结局(PRO)。
我们对接受 MAD 治疗的患者进行了前瞻性队列分析,前伸距离分别为最大前伸距离的 60%和 80%。使用家庭睡眠测试连续两晚评估 OSA 严重程度。PRO 包含 Epworth 嗜睡量表(ESS)和睡眠相关生活质量(FOSQ)。
20 例患者的中位超重体重指数为 27.1(四分位间距(IQR)16.3 kg/m²),主要为轻至中度 OSA,呼吸暂停低通气指数(AHI)为 18.3/h(IQR 17.7),ESS 为 12.5(IQR 8.0)。与 80%相比,60%的前伸显著但不显著地降低了 AHI(60%:11.2(IQR 5.5)/h,p=0.01;80%:12.9(IQR 18.0)/h,p=0.32),并改善了 ESS(60%:8.0(IQR 10.0);80%:10(IQR 9.0)),与治疗设置有关。未检测到 NNV 与 ESS 和 FOSQ 变化之间的相关性。较高的基线 NNV 与严重 OSA 相关(p=0.02),但与性别、超重或扁桃体切除术后无关。
OSA 的改善与较低的 NNV 相关;OSA 和 NNV 均与前伸程度有关。因此,较高的 NNV 并不能排除 MAD 治疗的候选者。PRO 变化不受 NNV 的影响,而是受一般 OSA 变化的影响。这些发现可能有助于定义和优化未来的研究设计,以确定客观 OSA 参数和 PRO 之间的主要结局决策。